Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 393
- 主要终点
- Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
研究概览
简要总结
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
- •Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity
排除标准
- •Malignant hypertension or sitting BP greater than 180/109 mmHg;
- •Severe heart failure, severe renal disease;
- •Recent history of myocardial infarction, stroke or transient ischemic attack;
- •History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
- •Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
- •Treatment with dis-allowed medication;
- •Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
- •History of drug and/or alcohol abuse
研究组 & 干预措施
Olmesartan medoxomil
Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
干预措施: Olmesartan medoxomil (Drug)
Olmesartan medoxomil
Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
干预措施: Furosemide oral tablets (Drug)
Losartan
Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
干预措施: Losartan (Drug)
Losartan
Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
干预措施: Furosemide oral tablets (Drug)
结局指标
主要结局
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
时间窗: Baseline to 12 weeks
次要结局
- Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;(Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks)
- Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;(Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks)
- Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;(Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks)
- Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;(Baseline to 12 and 52 weeks)
- Changes in serum creatinine after 12 and 52 weeks of treatment(Baseline to 12 and 52 weeks)
- Rate of patients per dose level after 12 and 52 weeks of treatment(Baseline to 12 and 52 weeks)
- Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment(Baseline to 4, 12, 24, 36 and 52 weeks)